Paratek, U.S. Department of Defense Enter Research Agreement to Study Omadacycline Against Biodefense Pathogens
October 11 2016 - 8:00AM
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today it has
entered into a Cooperative Research and Development Agreement
(CRADA) with the U.S. Army Medical Research Institute of Infectious
Diseases (USAMRIID) to study omadacycline against pathogenic agents
causing infectious diseases of public health and biodefense
importance. These studies are designed to confirm humanized dosing
regimens of omadacycline in order to study the efficacy of
omadacycline against biodefense pathogens, including Yersinia
pestis (plague) and Bacillus anthracis (anthrax). Funding support
for the trial has been made available through the Defense Threat
Reduction Agency (DTRA)/Joint Science and Technology Office (JSTO)
and Joint Program Executive Office for Chemical and Biological
Defense (JPEO-CBD)/Joint Project Manager Medical Countermeasure
Systems (JPM-MCS)/BioDefense Therapuetics (BDTX).
“Scientists at USAMRIID recognize the unique potential of
omadacycline as a novel once-daily oral antimicrobial agent and we
are extremely pleased to have the opportunity to work with USAMRIID
on these projects,” said Evan Loh, President and Chief Medical
Officer, Paratek. “Earlier research suggests the potential efficacy
of omadacycline against anthrax, plague, and other diseases of
public health and biodefense concern, which underscores the
importance of this partnership and the potential outcomes of these
studies. Considering omadacycline’s broad spectrum of activity,
oral bioavailability and robust safety and tolerability profile, we
believe it is an excellent candidate for study in these
infections.”
“We welcome the partnership with Paratek, DTRA-JSTO and
JPEO-CBD/JPM-MCS/BDTX to evaluate a new therapeutic that may
provide unique advantage in the important area of biodefense,” said
Colonel Bret Purcell, Ph.D., M.D. (Director of Translational
Sciences and Chief, Therapeutics Division, USAMRIID). “This
agreement with Paratek seeks to improve our understanding about the
potential utility of omadacycline against these pathogens.”
Under the terms of the CRADA, Paratek will provide omadacycline
and technical expertise to support USAMRIID’s conduct of the
pre-clinical pharmacokinetic studies and efficacy studies of
omadacycline against a variety of biodefense pathogens. Data
generated from these studies may support further development, which
could ultimately lead to the approval of omadacycline in the
treatment of these important biodefense pathogens.
About Paratek Pharmaceuticals, Inc.Paratek
Pharmaceuticals, Inc. is a biopharmaceutical company focused on the
development and commercialization of innovative therapies based
upon its expertise in novel tetracycline chemistry. Paratek's lead
product candidate, omadacycline, is the first in a new class of
tetracyclines known as aminomethylcyclines, with broad-spectrum
activity against Gram-positive, Gram-negative and atypical
bacteria. In June 2016 Paratek announced positive efficacy data in
a Phase 3 registration study in ABSSSI demonstrating the efficacy
and safety of omadacycline compared to linezolid. A Phase 3
registration study for community acquired bacterial pneumonia
(CABP) comparing IV-to-oral omadacycline to IV-to-oral moxifloxacin
was initiated in November 2015. Enrollment continues on track
to report top line data as early as the third quarter of
2017. A Phase 3 registration study in ABSSSI comparing
once-daily oral-only dosing of omadacycline to twice-daily
oral-only dosing of linezolid was initiated in August 2016. Top
line data are expected as early as the second quarter of 2017. A
Phase 1B study in uncomplicated urinary tract infections (UTI) was
initiated in May 2016. Enrollment is nearly complete with top line
data expected as early as the fourth quarter of 2016.
Omadacycline has been granted Qualified Infectious Disease Product
designation and Fast Track status by the U.S. Food and Drug
Administration.
Omadacycline is a new once-daily oral and IV, well-tolerated
broad spectrum antibiotic being developed for use as empiric
monotherapy for patients suffering from serious community-acquired
bacterial infections, such as acute bacterial skin and skin
structure infections, community acquired bacterial pneumonia,
urinary tract infections and other community-acquired bacterial
infections, particularly when antibiotic resistance is of concern
to prescribing physicians.
Paratek's second Phase 3 product candidate, sarecycline, is a
well-tolerated, once-daily, oral, narrow spectrum
tetracycline-derived antibiotic with potent anti-inflammatory
properties for the potential treatment of acne and rosacea in the
community setting. Allergan owns the U.S. rights for the
development and commercialization of sarecycline. Paratek retains
all ex-U.S. rights. Allergan initiated two identical Phase 3
registration studies in December 2014 for sarecycline for the
treatment of moderate to severe acne vulgaris. Top line data are
expected in the first half of 2017.
For more information, visit www.paratekpharma.com. About
United States Army Medical Research Institute of Infectious
DiseasesUSAMRIID’s mission is to provide leading edge
medical capabilities to deter and defend against current and
emerging biological threat agents. Research conducted at USAMRIID
leads to medical solutions—vaccines, drugs, diagnostics, and
information—that benefit both military personnel and civilians. The
Institute plays a key role as the lead military medical research
laboratory for the Defense Threat Reduction Agency’s Joint Science
and Technology Office for Chemical and Biological Defense. USAMRIID
is a subordinate laboratory of the U.S. Army Medical Research and
Materiel Command. For more information, visit www.usamriid.army.mil
[The information contained in this press release does not
necessarily reflect the position or the policy of the Government
and no official endorsement should be inferred.] Forward
Looking StatementCertain statements in this press release
are forward-looking statements. These forward-looking statements
are based upon Paratek's current expectations and involve
substantial risks and uncertainties. These risks and uncertainties
include, but are not limited to: (i) unexpected results may cause
the designs of the clinical trials to change, or the projected
timelines of the trials to be extended, (ii) omadacycline may not
progress to achieve indications of interest in any biodefense
pathogens, (iii) unexpected decline in the rates of patient
enrollment in the clinical trials, (iv) unforeseen adverse effects
experienced by patients resulting in a clinical hold, (v) failure
of patients to complete clinical trials, (vi) risks related
to regulatory oversight of the trials, (vii) the need for
substantial additional funding to complete the development and
commercialization of product candidates and (viii) risks that data
to date and trends may not be predictive of future results. These
and other risk factors are discussed under "Risk Factors" and
elsewhere in Paratek's Annual Report on Form 10-K for the year
ended December 31, 2015 and Paratek's other filings with the
Securities and Exchange Commission. Paratek expressly disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained herein.
CONTACTS:
Media Relations:
Michael Lampe
(484) 575-5040
michael@scientpr.com
Investor Relations:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
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